Status:
COMPLETED
Contrast-enhanced Ultrasound (CE-US) and Magnetic Resonance Imaging (MRI): Evaluating Plaque Neovascularisation
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Carotid Artery Stenosis
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The first goal of this study is to investigate whether CE-US is able to accurately identify and quantify neovascularisation in carotid artery plaques. Since this is one of the first studies systematic...
Detailed Description
Atherosclerosis is a systemic disease of the large arteries and the leading cause of death in Western society. The development of atherosclerosis involves the accumulation of lipids, cells and extrace...
Eligibility Criteria
Inclusion
- Subjects with a \>70% carotid artery stenosis who are scheduled for carotid endarterectomy. Such subjects will be eligible if the subject's attending physician of the department of surgery concurs with this assessment.
- Age 18 years or older
- Informed consent by signing informed consent form regarding this study
Exclusion
- Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
- Acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.
- Right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome.
- Pregnant and lactating women
- Documented allergy to contrast media or a renal clearance \<30 ml/minute
- Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00677963
Start Date
June 1 2009
End Date
April 1 2010
Last Update
April 20 2011
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX